by Dr. Yashashwini Reddy | Sep 6, 2025
Requirements of FDA for Training in Pharmaceuticals Training in the pharmaceutical industry is a critical requirement under cGMP regulations (21 CFR Parts 210 & 211). The FDA expects companies to have a structured, documented training system that ensures employees...
by Dr. Yashashwini Reddy | Sep 3, 2025
Common Causes of Low Quality in Pharmaceuticals Maintaining pharmaceutical quality is critical to ensure safety, efficacy, and regulatory compliance. Low-quality medicines can arise from multiple factors across raw materials, manufacturing, storage, and distribution....
by Dr. Yashashwini Reddy | Sep 2, 2025
🔹 Types of Stainless Steel in Pharmaceuticals 1. SS 304 / 304L (AISI 304) Composition: 18% Cr, 8% Ni 304L = low carbon version → better weldability, less sensitization Applications: Non-contact parts (frames, supports, furniture, piping for non-critical utilities)...
by Dr. Yashashwini Reddy | Sep 2, 2025
Generic Drugs Manufacturing: Opportunities and Obstacles Opportunities: Cost-effectiveness: Generic drugs offer patients affordable alternatives to branded medicines, increasing accessibility and market demand. Patent Expiry of Blockbuster Drugs: As patents of many...
by Dr. Yashashwini Reddy | Aug 27, 2025
Fungus in Pharmaceutical Cleanrooms: Types, Origins, and Decontamination 1. Introduction Fungal contamination in cleanrooms is a major risk to sterile product manufacturing, since fungal spores are ubiquitous, resistant, and can survive in harsh conditions. Even low...
